Quality Assurance Specialist

Job Description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special.

When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job it’s about your career and your future.

Your Role

We are hiring a Quality Assurance Specialist to facilitate document control, including document changes and change control, document review, and QMS maintenance.

• Support the review, approval, distribution, and timely processing of required quality documentation.
• Coordinate the processing of new documentation, document updates and changes.
• Monitor document change control processes, ensuring that all changes are properly documented, reviewed, and approved.
• Collaborate with cross functional teams to ensure that documentation is accurate and maintained in accordance with established standards and guidelines.
• Work closely with document owners and change owners in order to ensure any deficiencies are addressed and resolved.
• Provide thorough review of internal documents to ensure alignment with internal standards.
• Identify and address any non-conformances or gaps in document control processes.
• Maintain QMS record storage.
• Prepare documents and records for required transfer activities.
• Identify opportunities for process improvements within the document control function, driving efficiencies and enhancing effectiveness.
• Regularly review document control procedures and systems, recommending and implementing enhancements as necessary.
• Communicate changes to document control processes and requirements effectively to relevant stakeholders.
• Additional responsibilities as required.

Requirements

• Degree in relevant field.
• 2-3 years’ experience of document control and change control management within the pharmaceutical, medical device, or biotech industries.
• Strong computer skills, including proficiency in Microsoft Office Suite. Highly skilled in Excel.
• Strong knowledge of regulatory requirements (GMP, ISO, QSR, etc.).
• Familiar with document control management systems.
• Familiar with CAD software and interpreting technical drawings.
• Experienced with document indexing structures, scanning, and high volume printing.
• Excellent communication skills both verbal and written.
• Excellent organizational skills and attention to detail, with the ability to manage multiple tasks and priorities effectively.
• Ability to collaborate effectively with cross-functional teams.
• Analytical mindset with the ability to identify issues, analyze, and implement solutions.

Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success.

We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short / Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

Estimated pay (based on experience) : $80,000 - $100,000

Equal Opportunity Employment Statement :

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment.

Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination.

Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to : recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs.

Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived : race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

Requirements

Degree in relevant field. 2-3 years’ experience of document control and change control management within the pharmaceutical, medical device, or biotech industries.

Strong computer skills, including proficiency in Microsoft Office Suite. Highly skilled in Excel. Strong knowledge of regulatory requirements (GMP, ISO, QSR, etc.

Familiar with document control management systems. Familiar with CAD software and interpreting technical drawings. Experienced with document indexing structures, scanning, and high volume printing.

Excellent communication skills both verbal and written. Excellent organizational skills and attention to detail, with the ability to manage multiple tasks and priorities effectively.

Ability to collaborate effectively with cross-functional teams. Analytical mindset with the ability to identify issues, analyze, and implement solutions.